Cleared Traditional

K911485 - COLOR VIDEO CAMERA

K911485 is the FDA 510(k) clearance for COLOR VIDEO CAMERA by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K911485 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
132d
Days
Class 2
Risk

K911485 is an FDA 510(k) clearance for the COLOR VIDEO CAMERA. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 14, 1991 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K911485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date August 14, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 49
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K911485.
KSEA REVERSE VIDEO
K952482 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · Olympus America, Inc. · Nov 1994
EPM-3300 VIDEO PROCESSOR
K934918 · Pentax Precision Instrument Corp. · Feb 1994
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · Medline Industries, Inc. · Apr 1987
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · Olympus Corp. · Jan 1986
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · Life-Tech Intl., Inc. · Oct 1984